Therascreen EGFR RGQ PCR Kit
FDA premarket approval P120022/S016 · decided 2018-01-12
Approval details
- PMA number
- P120022
- Supplement
- S016
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Therascreen EGFR RGQ PCR Kit
- Generic name
- Somatic gene mutation detection system
- Applicant
- QIAGEN GmbH
- Date received
- 2017-07-28
- Decision date
- 2018-01-12
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- OWD
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Hilden
- Statement
- Approval for extending the labeling claim of the therascreen® EGFR RGQ PCR Kit to include detection of EGFR mutations L861Q, G719X and S768I, to aid in identifying patients with NSCLC for whom safety and efficacy of GILOTRIF® (afatininb) has been established.
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